Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232291
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-01-22
Brief Title:
Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine Placebo in Drug-resistant Depression
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine Placebo in Drug-resistant Depression
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An observational-comparative study without interfering with the treatment based on an operationalized interview
Detailed Description:
Patients with treatment-resistant depression constitute a significant proportion even 30 of patients diagnosed with major depressive disorder MDD Since 2014 there have been reports of a potential antidepressant effect of the R-ketamine stereoisomer At the UCK Department of Psychiatry a phase 2 clinical trial 2a has been conducted since 2022 with the use of R-ketamine in the form of an intravenous solution administered by an infusion pump to patients with drug-resistant depression sponsor Perception Neuroscience Inc protocol PCN-101-21 NCT05414422 The available data from studies indicate a potential treatment-transformative effect of the drug but do not provide comprehensive information on the long-term effects of treatment in terms of effectiveness tolerability and safety of R-ketamine use The study is cognitive and comparative study without interfering with the diagnostics treatment and rehabilitation It aims to collect effectiveness and safety observations within 12 months of participation in the PCN-101-21 study at quarterly intervals 3 6 9 12 months - 4 weeks with particular emphasis on exacerbations of the underlying disease hospitalization correction of psychotropic treatment or functional impairment requiring support from social security authorities The study does not involve additional diagnostic therapeutic or rehabilitation goals and is a retrospective analysis performed during a single visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None